Use of Prokinetics in Early Enteral Feeding in Preterm Infants

Sponsor

East Tennessee State University (Other)

Overall Status

Terminated

CT.gov ID

NCT01569633

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective of this study are:

To determine if medication help extreme preterm infants to tolerate feeding better by reaching full feeding earlier.2) Out of two medication; which one is better for efficacy 1) Erythromycin 2) Metoclopramide. Infants who meet inclusion criteria would be entered to study after parental consent. Infant would be blinded to care givers. Infants will be randomized to receive one of three medication for 7-14 days. If infants fail on one medication they will be allowed to crossover to other medication. Infant would be allowed to treat like other infants. Blindness can be broken if deem necessary by attending neonatologist.

Condition or Disease	Intervention/Treatment	Phase
Feeding Disorder Nutrition Disorder Infant,Premature	Drug: Metclopramide Drug: Erythromycin Drug: placebo	N/A

Detailed Description

Inclusion Critera:

Weight below 1250 grams
Age less than 14 days
Feeding intolerance; If feeding residual more than 30% on q3 hr feeding; 5 times out of 8 times, feeding residual more than 20% on q4 hr feeding 4 feeding out of 6 feeding or failure to advance feeding of more than 20ml/kg in 72 hrs.

Exclusion Criteria

GI malformation or perforation
Genetic disorder
Parents can't read English. After consent, if infants meet inclusion criteria, he would be allowed to receive one of the following three medication. 1) Erythromycin at 1mg/kg/dose q8 hr 2) Metoclopramide 0.1mg/kg/dose q8 hrs and Placebo. If infant fails to get better, he would be crossover to one of the remaining two.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Pilot Study for Use of Prokinetics in Early Enteral Feeding of Preterm Infants ; Double Blind; Cross Over Study Comparing Eryththromycin, Metoclopramide and Placebo

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Feb 1, 2014

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo This group of infant will not receive any medication but sugar water or placebo	Drug: placebo The dose of sugar water is 1 ml per 8 hours.
Active Comparator: Metclopramide This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs.	Drug: Metclopramide Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days. Other Names: reglan
Active Comparator: Erythromycin mediaction used to treat feeding disorder	Drug: Erythromycin Dose of erythromycin is 1 miligram per kilogram every eight hours

Arm

Intervention/Treatment

Placebo Comparator: Placebo

This group of infant will not receive any medication but sugar water or placebo

Drug: placebo

The dose of sugar water is 1 ml per 8 hours.

Active Comparator: Metclopramide

This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs.

Drug: Metclopramide

Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.

Other Names:

reglan

Active Comparator: Erythromycin

mediaction used to treat feeding disorder

Drug: Erythromycin

Dose of erythromycin is 1 miligram per kilogram every eight hours

Outcome Measures

Primary Outcome Measures

Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL [24 MONTHS]
Time to reach full enteral feeding in both infants. Which of the two medication help better in reaching full enteral feeding.

Secondary Outcome Measures

Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial. [24 months]
Duration of Total Parental Nutrition; duration of direct hyperbilirubinemia,

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 14 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Weight below 1250 grams
Age less than 14 days
Feeding intolerance; If feeding residual more than 30% on q3 hr feeding; 5 times out of 8 times, feeding residual more than 20% on q4 hr feeding 4 feeding out of 6 feeding or failure to advance feeding of more than 20ml/kg in 72 hrs.

Exclusion Criteria

GI malformation or perforation
Genetic disorder
Parents can't read English. After consent, if infants meet inclusion criteria, he would be allowed to receive one of the following three medication. 1) Erythromycin at 1mg/kg/dose q8 hr 2) Metoclopramide 0.1mg/kg/dose q8 hrs and Placebo. If infant fails to get better, he would be crossover to one of the remaining two.